First Holographic Cardiac Ablation Guidance System Receives FDA 510(k) Clearance

The mixed reality system allows electrophysiologists to visualize cardiac anatomy in true 3D in real time and provide handsfree interface. (Credit: BioSTL)

SentiAR , a pioneer in visualization technologies for surgical applications, has received FDA 510(k) clearance of its CommandEP™ system, the first holographic guidance system to be used during an invasive cardiac procedure. The system allows electrophysiologists to visualize 3D electroanatomic models in real time, via a wearable headset, and offers a truly hands-free control interface providing superior visualization, which allows them to navigate accurately within the heart during a cardiac ablation procedure.

The CommandEP system receives imaging data from the electroanatomic mapping systems and creates a 3D holographic image via SentiAR’s proprietary data flow and visualization algorithms. This patented system presents a 3D image of the patient’s heart showing the real-time position of the catheters within to the physicians via a wearable headset, currently Microsoft HoloLens. In addition to the proprietary algorithms, SentiAR deploys its unique, trade-secret AR engine to deliver uncompromising performance.

“The addition of SentiAR’s holographic guidance system provides electrophysiologists with a game-changing platform for mapping and interventional procedures,” says John K. Triedman, MD, chief of cardiac electrophysiology at Boston Children’s Hospital. “The ability to see the models in 3D in real-time, to look inside chambers and around corners while moving and rotating the model allows us to gain a better and more precise understanding of cardiac anatomy. We anticipate being able to easily integrate the CommandEP system with our existing EP lab workflows. The powerful tools CommandEP provides have real potential to allow electrophysiologists to perform more accurate procedures.”

SentiAR successfully completed a clinical study with the CommandEP system at St. Louis Children’s and Barnes Jewish Hospitals. In addition to utilizing the CommandEP system during the procedure, physicians were asked to perform a navigation study by targeting specific points within the patient anatomy. Each navigation exercise was completed with the CommandEP system and repeated again with standard visualization tools.

The order of CommandEP and standard visualization tools utilization was randomized to avoid creating a bias. A total of 150 navigation points were collected in 16 patients who were undergoing cardiac ablation surgery. The results of the comparative analysis showed a 44% reduction in mean navigation error with the utilization of CommandEP system over the standard visualization tools. The results of this study were published in Journal of American College of Cardiology: Clinical Electrophysiology.

“CommandEP represents a huge leap forward in cardiac ablation technology,” says Paul Buckman, member of the board of directors of SentiAR. “Our clinical and strategic partners are thrilled with the patient data showing improved navigation, and together we look forward to putting CommandEP into the hands of electrophysiologists worldwide.”

“SentiAR is dedicated to improving precision and reducing complexity for all interventional procedures” says Berk Tas, CEO of SentiAR. “SentiAR’s holographic ablation guidance system is our first of many products to come that will revolutionize interventional procedures. SentiAR’s unique AR engine, proprietary data flow, visualization algorithms, and patented handsfree interface provide physicians with an unprecedented connection to their digital tools during procedures. We are giving physicians superhuman capabilities to integrate their digital environments so they can focus on patients and their treatment.”

The CommandEP system is now available for sale in the United States with distribution expected to begin in 2021. The system’s unique capabilities provide physicians the tools they need in a handsfree fashion and open architecture allows easy integration into any interventional procedure facility worldwide.

BioGenerator, the investment arm of BioSTL, and Cultivation Capital Life Sciences Fund are the lead investors in SentiAR. Charlie Bolten, senior vice president of BioGenerator, and William Schmidt, managing director of Cultivation Capital’s Life Sciences Fund, are members of SentiAR’s board of directors.